Effect of stopping proton pump inhibitors (PPI) on the incidence of Clostridium difficile diarrhoea (CDD)
| ISRCTN | ISRCTN04808359 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04808359 |
| Secondary identifying numbers | N0185139377 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 17/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr R Cunningham
Scientific
Scientific
Microbiology Dept.
Level 05
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effect of stopping proton pump inhibitors (PPI) on the incidence of Clostridium difficile diarrhoea (CDD) |
| Study objectives | To determine whether restricting unnecessary use of PPIs reduces the incidence of Clostridium difficile diarrhoea in hospital inpatients |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Diarrhoea |
| Intervention | Randomised controlled intervention study to determine whether restriction of PPI use to National Institute for Clinical Excellence (NICE) approved indications has an effect on subsequent incidence of Clostridium difficile diarrhoea (CDD). Interventions compared are stopping PPIs versus non stopping PPIs. |
| Intervention type | Other |
| Primary outcome measure | Incidence of CDD |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 11/03/2004 |
| Completion date | 28/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 400 patients aged 65 or over admitted to hospital via Medical Assessment Unit (MAU) who are taking PPIs. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 11/03/2004 |
| Date of final enrolment | 28/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Plymouth Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
